Evaluation of SCOUT DS in Subjects With Type 2 Diabetes (TCOYD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VeraLight, Inc.
ClinicalTrials.gov Identifier:
NCT01346033
First received: April 28, 2011
Last updated: December 3, 2012
Last verified: December 2012

April 28, 2011
December 3, 2012
October 2010
October 2010   (final data collection date for primary outcome measure)
Validation of SCOUT DS algorithm for detecting known type 2 diabetes [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes
Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01346033 on ClinicalTrials.gov Archive Site
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Evaluation of SCOUT DS in Subjects With Type 2 Diabetes
An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 Diabetes

The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes.

Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the SCOUT DS diabetes screening algorithm.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

Attendees of the Taking Control of Your Diabetes Health Fair, San Diego CA Convention Center

Type 2 Diabetes
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Those with Type 2 diabetes
All subjects have been diagnosed with type 2 diabetes.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age greater than or equal to 18 years
  2. Self-reported diagnosis of type 2 diabetes

Exclusion Criteria:

  • Not diagnosed with type 2 diabetes

    • Diagnosed with type 1 diabetes
    • Known to be pregnant (Self Reported)
    • Receiving dialysis or having known renal compromise
    • Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
    • Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01346033
VL-2714
No
VeraLight, Inc.
VeraLight, Inc.
Not Provided
Principal Investigator: Martin L Kabongo, MD,PhD Accelovance San Diego
VeraLight, Inc.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP